KAI-7535 for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how the body processes KAI-7535, a potential new drug, in individuals living with obesity or who are overweight. Researchers are testing various timings and conditions for taking the medication, such as in the morning with or without food, and in the evening. They seek to determine how these factors influence the medication’s absorption and action in the body. Suitable participants should have a body mass index (BMI) between 25 and 40 and be generally healthy without major medical issues. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that KAI-7535 is as safe as other medicines that control blood sugar levels, indicating that most people tolerate it well. In earlier research, some participants experienced side effects like nausea and vomiting, but these were the most common and manageable. Researchers have tested both single and multiple doses of KAI-7535 in people, and results suggest it is generally safe. The treatment also showed promise in aiding weight loss, which is encouraging for obesity treatment. However, as with any new treatment, side effects may occur, so it's important to weigh both the benefits and risks before joining a trial.12345
Why are researchers excited about this trial's treatments?
Unlike the standard obesity treatments, which often involve lifestyle changes, medications like orlistat, or procedures such as bariatric surgery, KAI-7535 offers a different approach. One exciting feature of KAI-7535 is its novel dosing schedule, with options for morning or evening administration, providing flexibility for patients who may struggle with traditional daytime regimens. Additionally, the treatment's potential effectiveness when taken either with food or after fasting allows researchers to explore how different dosing conditions might optimize weight loss outcomes. These unique aspects could lead to a more personalized treatment option for obesity, making KAI-7535 an intriguing candidate in the fight against this condition.
What evidence suggests that this trial's treatments could be effective for obesity?
Research has shown that KAI-7535 yields promising results in weight loss. In one study, participants lost an average of 4.38 kg (about 6.63% of their body weight) in just 29 days. This trial will evaluate KAI-7535 under different dosing conditions: morning dosing with a meal, morning dosing after fasting, and evening dosing. The drug's ability to promote noticeable weight loss makes it a potential option for managing obesity. Additionally, KAI-7535 is considered as safe as other similar treatments.12346
Are You a Good Fit for This Trial?
This study is for individuals who are living with obesity or overweight. The main goal is to see how a low-fat meal and taking the drug KAI-7535 in the evening affect its levels in the body.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive KAI-7535 with different dosing schedules: morning fed, morning fasted, and evening dosing
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Evening Dosing
- Low-fat Meal
Trial Overview
The trial is testing KAI-7535, focusing on how food intake and dosing time might change the way this drug works in people who are obese or overweight.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Participants will receive KAI-7535 in the morning following a meal on dosing days.
Participants will receive KAI-7535 in the morning following an overnight fast on dosing days.
Participants will receive KAI-7535 in the evening on dosing days.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kailera
Lead Sponsor
Citations
A Study to Investigate the Effect of a Low-fat Meal and ...
The primary objective of this study is to evaluate the effect of a meal and evening dosing on the pharmacokinetics (PK) of KAI 7535 in healthy participants ...
2.
trial.medpath.com
trial.medpath.com/clinical-trial/361f60f41006eba1/nct07294898-kai-7535-effect-low-fat-meal-obesity-overweightA Study to Investigate the Effect of a Low-fat Meal and Evening ...
The primary objective of this study is to evaluate the effect of a meal and evening dosing on the pharmacokinetics (PK) of KAI 7535 in healthy ...
PowerPoint 演示文稿
Conclusions: ➢ Both SAD and MAD of HRS-7535 showed acceptable safety profile and favorable PKs/PDs. ➢ The obvious reductions in body weight could be observed ...
Safety, pharmacokinetics and pharmacodynamics of ...
On day 29 in the MAD part, the mean (percentage) reduction in body weight from baseline was 4.38 kg (6.63%) for participants who received HRS-7535, compared ...
Hengrui to file obesity shot in China after phase 3 win
Statistical modelling suggests that the drug may be able to achieve 48-week weight loss of 23.6%, which would suggest a competitive efficacy ...
Hengrui, Kailera say dual-acting obesity shot succeeds in ...
Hengrui and Kailera didn't disclose specific safety data, only ... A large group of dosing pens for subcutaneous injection of anti-obesity ...
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